A Study to Evaluate if ID-085 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects

December 18, 2018 updated by: Idorsia Pharmaceuticals Ltd.

A Two-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of ID-085 in Healthy Subjects

The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of single- and multiple-ascending doses of ID-085 in healthy subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is designed in two parts, A and B.

Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose.

Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom, LS2 9LH
        • Covance Clinical Research Unit - Clinical Pharmacology Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent in the local language prior to any study-mandated procedure.
  • Healthy male subjects for Part A, healthy male and female subjects for Part B aged between 18 and 55 years (inclusive) at screening.
  • No clinically significant findings on physical examination at screening.
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening.

Exclusion Criteria:

  • History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
  • Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
  • Pregnant or lactating women.
  • Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of the excipients.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ID-085, single ascending dose (Part A)
ID-085 administered at different single dose levels in a sequential manner, and in a maximum of 6 dose levels starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort)
Drug: ID-085
Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
Placebo Comparator: Placebo, single ascending dose (Part A)
Matched placebo administered as single ascending doses in parallel to ID-085
Drug: Placebo oral capsule
Placebo capsules matching ID-085 capsules
Experimental: ID-085 multiple ascending dose (Part B)
ID-085 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be either 10 or 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A
Drug: ID-085
Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
Placebo Comparator: Placebo, multiple ascending dose (Part B)
Matched placebo administered as single ascending doses in parallel to ID-085
Drug: Placebo oral capsule
Placebo capsules matching ID-085 capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in PQ/PR interval (ms)
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in QRS interval (ms)
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in QT corrected for Bazett's formula (QTcB) interval (ms)
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in RR interval (ms)
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in heart rate (bpm)
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
ECG variables are to be recorded using a standard 12-lead ECG
up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in supine systolic blood pressure
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
mm Hg
up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in supine diastolic blood pressure
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
mm Hg
up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in supine pulse rate
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
bpm
up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Changes from baseline in body weight
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
kg
up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Number of patients with treatment-emergent AEs and SAEs for each treatment period
Time Frame: up to 48 hours post-dose (Part A); up to Day 10 (Part B)
Treatment-emergent AEs and treatment-emergent serious AEs
up to 48 hours post-dose (Part A); up to Day 10 (Part B)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: up to Day 3 (Part A), up to Day 10 (Part B)
up to Day 3 (Part A), up to Day 10 (Part B)
Time to reach Cmax (tmax)
Time Frame: up to Day 3 (Part A), up to Day 10 (Part B)
up to Day 3 (Part A), up to Day 10 (Part B)
Terminal half-life [t(1/2)]
Time Frame: up to Day 3 (Part A), up to Day 10 (Part B)
up to Day 3 (Part A), up to Day 10 (Part B)
Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
Time Frame: up to Day 3 (Part A), up to Day 10 (Part B)
up to Day 3 (Part A), up to Day 10 (Part B)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Idorsia Pharmaceuticals Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID-085-101
  • 2017-004124-30 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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